Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction
The aim of this study is to investigate associations between early structural cellular injury and microvascular alteration with progression of septic organ dysfunction according to total SOFA-Score (an ICU-scoring system - the Sequential Organ Failure Assessment Score). Patients will be monitored for renal (TIMP-2, IGFBP7), and intestinal biomarkers (plasma i-FABP) in conjunction with kidney and muscle vascular bed microvascular perfusion analysis assessed by contrast-enhanced ultrasonography (CEUS). In parallel, a comprehensive analysis of patients' immunological status will be conducted using an established, on-site immune monitoring panel.
The ultimate goal of this study is an early identification of septic patients developing multiorgan dysfunction which may facilitate a timely novel intervention in the future to improve outcome.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
Bavaria
-
Regensburg, Bavaria, 독일, 93053
- Department of Surgery, University Hospital Regensburg
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Patients ≥18 years of age with severe sepsis and fulfill the following criteria at the admission to ICU:
- Peritonitis (abdominal infection) and performed source control (either surgically or interventionally)
- 2 or more criteria for systemic inflammatory response syndrome (temperature >38° or<36°; heart rate >90 beats per minute; respiratory rate >20 breaths per minute or paCO2 <32 mmHg; white blood cell count >12,000/mm3, <4000mm3 or >10% immature forms) and serum lactate level of 4mmol/l and more or refractory hypotension - mean arterial pressure <65mmHg or systolic blood pressure <90mmHg after fluid challenge of 1000ml or more /30min
- Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Written informed consent prior to any study procedures
Exclusion Criteria:
- Pre-existing renal-replacement therapy in the pre-operative course
- Pre-existing shock
- Acute coronary syndrome
- Active hemorrhage
- Trauma
- Known allergy to ultrasound contrast media
- Anemia with hemoglobin concentration < 7g/dl
- Patients not able to give written informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Assessment of early post-operative course of novel cellular injury biomarkers as well as microvascular perfusion in critically ill patients with severe sepsis and to collection any first evidence of the association of these markers with the SOFA-Score
기간: 60 weeks
|
60 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
28 day mortality
기간: 60 weeks
|
60 weeks
|
|
|
90 day mortality
기간: 60 weeks
|
60 weeks
|
|
|
Length of ICU stay
기간: 60 weeks
|
60 weeks
|
|
|
Length of hospital stay
기간: 60 weeks
|
60 weeks
|
|
|
Early post-operative course of microvascular perfusion of the kidney and muscle vasculature bed using CEUS
기간: 60 weeks
|
60 weeks
|
|
|
Incidence of acute kidney injury (AKI) within the first 48 hours as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation
기간: 60 weeks
|
60 weeks
|
|
|
Incidence of acute kidney injury (AKI) within the first 7 days as based on current Kidney Disease: Improving Global Outcomes (KDIGO) recommendation
기간: 60 weeks
|
60 weeks
|
|
|
Need for renal replacement therapy (RRT) after admission to ICU
기간: 60 weeks
|
60 weeks
|
|
|
Identification of an "immunological fingerprint" indicating multi-organ dysfunction
기간: 60 weeks
|
Flow cytometry
|
60 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Marc H Dahlke, Prof. Dr., University Hospital Regensburg
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .